Kornimate/medical-research-clean huggingface dataset:
insulin regimens and vascular functions

Conditions: Type 2 Diabetes

Summary: vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. the aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. the effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients. the aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function. patients will be recruited in the department of endocrinology-diabetology-nutrition of jean verdier hospital, ap-hp, and the department of endocrinology and metabolism of avicenne hospital, bobigny, ap-hp, france. after an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them. investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. we will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: sphygmocor®, finapres®, laser-doppler et endopat2000®. body composition will be evaluated with impedance maestri and bodpod®.

Eligibility criteria:
inclusion criteria: * consent patient * adults from 30 to 72 years old * type 2 diabetic patients for at least 1 year * able to self measure capillary blood glucose * body mass index 20-37 kg/m², * hba1c 7.1-12% under metformin and sulfunyreas therapy for at least 2 months * anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months exclusion criteria: * pregnancy * other antidiabetic medication in the previous 2 months, * anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months, * insulin allergy, * uncontrolled preproliferative or proliferative diabetic retinopathy * uncontrolled hypertension * renal failure(creatinin clearance \<40 ml/min) * hepatocellular deficiency (prothrombin time \<70%) * anemia * peripheral occlusive arterial disease * cardiac arrhythmia

Keywords: insulin therapy vago-sympathetic activity arterial stiffness endothelial function
clinical evaluation of noninvasive oct angiography using a zeiss oct prototype to compare to fluorescein angiography

Conditions: Diabetic Retinopathy

Summary: clinical evaluation of noninvasive oct angiography using a zeiss oct prototype to replace fluorescein angiography.

fluorescein angiography (fa) is the standard and generally accepted method to identify vascular features in the retina, detecting capillary dropout and neovessel growth. its value is undeniable and is a routine ophthalmological examination. however, it requires intravenous injection of fluorescein, which can cause nausea, vomiting and, rarely, anaphylaxis and death. new oct angiography methods can detect, noninvasively red blood cells flow and, therefore, identify well the retinal vasculature. it is crucial and of major interest to evaluate the clinical utility of this new methodology comparing this information with the one obtained from fluorescein angiography.

Eligibility criteria:
inclusion criteria: * all patients with clinical indication for fluorescein angiography in their clinical practice exclusion criteria: * subjects with a pacemaker of similarly critical electronic device * subjects with severe ocular media opacities * subjects with corneal abnormalities
new data analysis methods for actigraphy in sleep medicine

Conditions: Obstructive Sleep Apnea; Restless Leg Syndrome; Insomnia

Summary: the purpose of this study is to develop statistical and informatics tools for analyzing and visualizing actical™ (actigraphy) data linked to fatigue in sleep medicine center patients.

an actical™ is a watch-like device attached to the wrist that uses an accelerometer to measure movement nearly continuously over several days. the american academy of sleep medicine practice parameters report that actigraphy is a useful tool for detecting sleep in healthy individuals, assessing specific aspects in insomnia and restless legs syndrome, circadian-rhythm disorders, and excessive sleepiness. concurrent with these recommendations is an increased interest in the use of actigraphy as a tool for objectively measuring fatigue. with improved high-end statistical methods for analyzing this data, actigraphy has the potential to become more important as an objective diagnostic tool for determining fatigue, sleep abnormalities and assessing response to treatment.

Eligibility criteria:
inclusion criteria: * patient presenting to the washington university sleep medicine center for evaluation of obstructive sleep apnea syndrome, restless legs syndrome, or insomnia * older than 18 years of age * ability to consent to participation in the study * willingness to wear the actical™ for two 7 day periods and to return the equipment promptly exclusion criteria: * inability to provide valid consent * pregnancy * night or rotating shift workers

Keywords: sleep disorders obstructive sleep apnea restless leg syndrome insomnia actigraphy
validity reliability of the dubousset functional test in stroke patients

Conditions: Stroke Syndrome; Balance; Distorted; Walking, Difficulty

Summary: increased muscle tone, decreased normal range of motion, and functional impairments may result in decreased load on the affected limb, deviations in gait patterns, balance and coordination disorders in individuals with stroke. in the literature, there are many scales that evaluate balance and functional performance in stroke. however there is no validity and reliability study of dubousset function test developed to evaluate balance and functional performance of stroke. for this reason, the aim of study is to examine the validity and reliability of dubousset function test in stroke patients.

while the ambulation ability is completely lost in some patients after stroke, impaired balance reactions and increased postural oscillations cause an increase in the fear of falling and the risk of falling in stroke patients. these disturbances cause stroke patients to make more effort to balance while standing. balance assessment performed in individuals with stroke determines the risk of falling and is important in preventing complications that may develop due to loss of balance. dubousset functional test (dft); a conceptually practical four-component assessment test has been proposed by dr. jean dubousset to assess the functional capacity of adult individuals. the validity of the test was made in individuals with spinal deformity. dft; it consists of four components: getting up from a chair without arms and walking 5 meters forward and backward, descending and climbing steps, transition from standing to sitting on the ground, and the dual task test in which the individual walks while counting down from 50 at the same time. in the literature, there are many scales that evaluate balance and functional performance in stroke. however there is no validity and reliability study of dubousset function test developed to evaluate balance and functional performance of stroke. for this reason, the aim of study is to examine the validity and reliability of dubousset function test in stroke patients

Eligibility criteria:
inclusion criteria: * 18 years or older, * getting a diagnosis of stroke, * not having cooperation and communication problems * to be able to walk 10 m independently with or without device exclusion criteria: * have a neurological or orthopedic problem other than stroke that will affect functionality and balance * individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.
real-time feedback of syntax score category during coronary angiographies to improve appropriateness of coronary revascularization for patients with stable coronary artery diseases: a before-and-after controlled study

Conditions: Syntax Score; Appropriateness; Coronary Revascularization

Summary: the syntax score (ss) has been recommended by clinical guideline and appropriate use criteria for coronary revascularization (cr) to provide guidance on optimal treatment strategies for patients with stable coronary artery diseases (cad). however, discrepancy in ss between angiographic core lab (acl) and cardiologists has been found. whether the misestimate will lead to inappropriate cr and whether a ss intervention will improve cr appropriateness in patients with stable cad remain unknown. thus, our study aims at evaluating whether a real-time feedback from acl rightafter the angiographies will improve cr appropriateness. a before-and-after controlled trial was designed. in the first period of time, stable cad patients undergoing elective coronary angiographies with at least one coronary lesion stenosis ≥ 50% from one chinese cardiac center will be continuously recruited as the control group. in the second period, eligible patients will be recruited continuously and a real-time ss category feedback from acl rightafter the angiography will be given to the cardiologists. appropriateness of treatment strategies in two groups will be analyzed to determine whether a real-time ss feedback can improve the treatment appropriateness. the appropriateness of treatment strategies will be adjudicated by chinese version appropriate use criteria for cr.


Eligibility criteria:
inclusion criteria: 1. undergo elective coronary angiography with at least one coronary lesion stenosis ≥ 50%; 2. patients with stable coronary artery diseases (stable angina, no or non-ischemic symptom); 3. written informed consent. exclusion criteria: 1. have prior cabg; 2. have stage pci; 3. have no assigned scenario in chinese appropriate use criteria.
evaluation of patient and lesion specific prognostic factors for standard radioimmunotherapy

Conditions: Follicular Lymphoma

Summary: merit-nhl as an addendum to the international registry of radioimmunotherapy (rit registry) pooling clinical data of patients who suffered from a non-hodgkin´s lymphoma also includes the documentation of the respective fdg-pet and ct-image files in an online archive. based on these documented clinical and imaging data, the merit study group centrally performs an intra- as well as interindividual evaluation of follicular cd20+ lymphoma lesions before and after radioimmunotherapy. according to this, the aim of the merit-nhl study is to prospectively identify yet unknown patient- and lesion specific prognostic factors predicting patient´s outcome in line with the therapeutic modality radioimmunotherapy.


Eligibility criteria:
inclusion criteria: * standard radioimmunotherapy with 90-yttrium-labeled anti-cd20-antibodies in treatment of relapsed and/or refractory follicular nhl or partial remission after induction chemotherapy * finding of at least one image-guided measurable lymphoma lesion * existence of fdg-pet- and ct-image data of at most 8 weeks before treatment * signed patient´s agreement for rit registry and merit-nhl exclusion criteria: * other therapy modalities than standard radioimmunotherapy (e.g. consolidation) * solely cns-lymphoma or primary effusion lymphoma

Keywords: radioimmunotherapy follicular non-hodgkin´s lymphoma fdg-pet prognostic factors multicenter study
study of efficacy and safety of dabrafenib and trametinib combination therapy in japanese patients with braf v600e stage iv nsclc

Conditions: Non-Small-Cell Lung Cancer

Summary: this is an open-label, multicenter, non-randomized, single arm, phase ii study to assess efficacy and safety of the dabrafenib and trametinib combination in japanese patients with any line, stage iv nsclc harboring a confirmed braf v600e mutation. patients will receive oral dabrafenib twice daily and oral trametinib once daily combination therapy. patients may continue study treatment until disease progression, unacceptable adverse events, start of a new anti-cancer therapy, consent withdrawal, death, or end of the study. patients who have met the criteria for disease progression (pd) according to recist v1.1 may continue to receive study treatment if the investigator believes the patient is receiving clinical benefit and the patient is willing to continue on study treatment. after discontinuation of study treatment, all patients will be followed for survival until death, lost to follow-up, withdrawal of consent, or end of study.


Eligibility criteria:
inclusion criteria: * histologically- or cytologically-confirmed diagnosis of nsclc stage iv (according to ajcc staging 7th edition) * presence of a braf v600e mutation in lung cancer tissue. braf v600e mutation tested by local laboratory (e.g. study center laboratory, local laboratory company) with proper quality control and license to operation by local health authority is allowed. * measurable disease according to recist v1.1. exclusion criteria: * previous treatment with a braf inhibitor (including but not limited to dabrafenib, vemurafenib, encorafenib, and xl281/bms-908662) or mek inhibitor (including but not limited to trametinib, cobimetinib, binimetinib, azd6244, and rdea119) prior to start of study treatment * patients with brain metastases are excluded if their brain metastases are: * symptomatic or * treated (surgery, radiation therapy) but not clinically and radiographically stable 3 weeks after local therapy (as assessed by contrast enhanced magnetic resonance imaging \[mri\] or computed tomography \[ct\]), or * asymptomatic and untreated but \>1 cm in the longest dimension * history of malignancy with confirmed activating ras mutation at any time. * history of interstitial lung disease or pneumonitis * a history or current evidence of retinal vein occlusion (rvo) * current evidence of unstable aneurysm or one that needs treatment other protocol-defined inclusion/exclusion may apply.

Keywords: non-small-cell lung cancer nsclc dabrafenib trametinib japanese patients braf v600e mutation positive metastatic stage iv
3d maternal fetal bonding

Conditions: Maternal-Fetal Relations; Paternal Behavior; Maternal Behavior

Summary: to determine whether 3d models of fetus' face created from 3d ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. half of participants will receive 3d model and half will receive a picture of 3d ultrasound of their baby.


Eligibility criteria:
inclusion criteria: * age - female 19-45 years of age; male \> 19 years of age * currently pregnant (\< 32 weeks gestation) * have normal 20-week ultrasound exclusion criteria: * having received more than 3 ultrasounds prior to study * medical need for additional ultrasounds * multiple fetuses * \> 31 weeks gestation
short-term effects of whole-body vibration on upper extremity function in subjects with poststroke hemiplegia

Conditions: Rehabilitation; Stroke; Hemiplegia; Physical Therapy Modalities; Electromyography; Upper Extremity; Recovery of Function; Vibration

Summary: to investigate the effect of whole body vibration on upper limb motor function in hemiplegic patients with subacute stroke


Eligibility criteria:
inclusion criteria: * after unilateral stroke 1 to 6 months * an ischemic or hemorrhagic poststroke hemiplegia * no cognitive impairment * able to reach brunnstrom stage ii or above in the proximal and distal parts of the arms * no excessive pain in the more affected upper extremity * all subjects agreed to participate in the study after receiving explanations regarding the purpose and procedures of the experiment, and they signed an informed consent statement before participation exclusion criteria: * unsteadiness * accompanied by important organs (such as heart, liver, lung, kidney) dysfunction or malignant tumors * contraindications to general vibration training exist * combined with other diseases causing upper limb dysfunction

Keywords: whole-body vibration stroke hemiplegia upper extremity rehabilitation training muscular surface emg vibration training
functional mrc with eovist for acute cholecystitis

Conditions: Acute Cholecystitis

Summary: functional magnetic resonance cholangiography (fmrc) with gadoxetate disodium (eovist) is an accurate method of diagnosing acute cholecystitis.

primary objective: to determine the accuracy of fmrc in evaluating patients with suspected cholecystitis. secondary objective: to compare the results of fmrc with conventional hepatobiliary scintigraphy.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * symptoms of right upper quadrant pain with ambiguous us (and/or ct) findings * standard of care nuclear medicine hepatobiliary scan to rule out acute cholecystitis - exclusion criteria: * scheduled for emergent surgery, or is otherwise determined by the investigator that the subject is clinically unsuitable for the study * glomerular filtration rate (gfr) below 60 ml/min/1.73m2 * total bilirubin above 3.0 mg/dl * inability to provide informed consent (altered or diminished mental status) * allergic to morphine * known or suspected hypersensitivity to gadolinium-based agents * the standard mri contraindications apply, including but not limited to: having a pacemaker or other implanted electronic device, metal foreign bodies within the eye, aneurysm clips, heart valve prosthesis, vascular stents, coils, intrauterine devices (iuds), penile implants, inferior vena cava (ivc) filters, gunshot wounds with retained bullet fragments. * pregnant or breast-feeding -

Keywords: acute cholecystitis
optimal treatment for spinal cord injury associated with cervical canal stenosis (oscis) study

Conditions: Spinal Cord Injury

Summary: controversy exists regarding the optimal management of acute traumatic cervical spinal cord injury (sci), especially those without bone injury. although surgical decompression is often performed in sci patients with cervical canal stenosis, efficacy and timing of surgery continues to be a subject of intense debate. in this randomized controlled trial, the investigators compare two strategies: early surgery within 24 hours after admission and delayed surgery following at least 2 weeks of conservative treatment. the purpose of this study is to examine whether early surgery would result in greater improvement in motor function as compared with delayed surgery.


Eligibility criteria:
inclusion criteria: * patients with acute traumatic cervical spinal cord injury (at c5 or below) admitted within 48 hours after injury 1. no bone injury (no fracture or instability) 2. american spinal injury association (asia) impairment grade c 3. cervical canal stenosis due to preexisting conditions such as spondylosis and ossification of the posterior longitudinal ligament (opll) exclusion criteria: 1. unstable medical status 2. difficult to undergo surgery within 24 hours after admission 3. impaired consciousness or mental disorder that precludes neurological examination 4. difficult to obtain informed consent in japanese

Keywords: incomplete spinal cord injury cervical canal stenosis ossification of the posterior longitudinal ligament surgery decompression
imaging biomarkers of the effects of a mixed exercise program

Conditions: Sarcopenia

Summary: the aim is quantify, correlate and establish the diagnostic and prognostic value of the variation of the image biomarkers obtained by magnetic resonance (muscle volume, morphological, biochemical and structural biomarkers) longitudinally in fragile or pre-frail elders with sarcopenia after a mixed physical training of strength and myofascial self-conditioning. this project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. 60 elderly with sarcopenia and frailty (intervention group, n=30; control group, n=30) will participate in the study. intervention group participants will perform 6-months mixed exercise program consisting in high-intensity strength training and self-myofascial conditioning. data will be take trough 2 measurements that will be take place at baseline and post-intervention. criteria of frailty, criteria of sarcopenia, sociodemographic, clinics, kinanthropometric, functional, nutritional and confusing variables will be evaluated. moreover, magnetic resonance images will be performed to obtain muscle volume, morphological, biochemical and structural biomarkers.


Eligibility criteria:
inclusion criteria: * patients of both genders, * aged 70 years old or more, * with habitual residence in valencia, * with independent wandering (they can have technical aids, but not from someone else) * that meets fried's pre-frailty or frailty criteria * egwsop's sarcopenia criteria * who has agreed to participate in the study and signed the informed consent exclusion criteria: * patients with life expectancy less than six months * institutionalized patients * patients with severe visual or auditory deficits * patients with contraindication in the performance of physical exercise (cardiovascular risk factors) * patients with contraindications for the magnetic resonance study, especially carriers of non-compatible pacemakers, neurostimulators, cochlear implants and intracranial aneurysm clamping. * patients with severe psychiatric illness or moderate or severe cognitive impairment. * patients who refuse to sign the informed consent.

Keywords: sarcopenia frailty strength myofascial self conditioning image biomarkers
efficacy of ketoprofen before intrauterine device insertion

Conditions: Pain Relief

Summary: iud can cause pain and discomfort in several ways: use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the iud insertion tube, and removing the tube; and placement of the device in the uterus.

to minimize the discomfort and the hazards of an iud insertion, several measures have been proposed including nsaids, anxiolytics, and local anesthetics in the form of intracervical gel, cervical and para-cervical block, but there have not done enough studies about their effectiveness. according to the review published in the cochrane, non-steroidal anti-inflammatory drugs and misoprostol are not effective on reducing an iud insertion pain.

Eligibility criteria:
inclusion criteria: * women not taken analgesics or anxiolytics in the 24 hours prior insertion * women not taken misoprostol prior to insertion * no contraindication to non-steroidal drugs * women who will accept to participate in the study exclusion criteria: * any contraindication to device placement